Healthy Subjects
Conditions
Keywords
CP1050, Phase 1, Healthy subjects
Brief summary
This is a Phase I, first-in-human, double-blind, single-centre, randomised, placebo-controlled, single and multiple oral dose study in healthy subjects conducted in 4 parts (Part 1; Single-ascending dose, Part 2; Food-effect evaluation, Part 3; Gender-effect evaluation, Part 4; Multiple-ascending dose).
Interventions
DRUGCP1050 or Placebo
Randomised, double-blinded, placebo-controlled
Sponsors
Curadim Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Caucasian males or females between 18 and 55 years of age (inclusive). * A body weight of ≥60 kg for males and ≥50 kg for females, with a body mass index (BMI) ranging from 18.0 to 30.0 kg/m2 (inclusive). * Healthy and free from clinically significant illness or disease.
Exclusion criteria
* Presence or history of any clinically significant disease that could interfere with the objectives of the study or the safety of the subject in the opinion of the Investigator. * Participation in more than 3 clinical studies involving administration of an IMP in the past one year, or any study within 12 weeks. * Clinically significant abnormalities in ECG or laboratory tests.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with abnormal physical examinations | Up to 21 days | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of physical examinations |
| Incidence and severity of any drug-related adverse events | Up to 21 days | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events |
| Number of subjects with abnormal vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate and oral body temperature) | Up to 21 days | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of vital signs |
| Number of subjects with abnormal clinical laboratory tests (including clinical chemistry, haematology and urinalysis) | Up to 21 days | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of clinical laboratory tests |
| Number of subjects with abnormal 12-lead safety ECG (including heart rate, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected for heart rate using Fridericia's method [QTcF]) | Up to 21 days | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead safety ECG |
| Number of subjects with abnormal 12-lead continuous (24-hour) ECG (including mean hourly heart rate and incidence of arrhythmia assessed as per the ECG Alert Criteria) | Up to 21 days | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead continuous (24-hour) ECG |
| Number of subjects with abnormal Pulmonary function tests (including FEV1, FVC, FEF25-75 and DLCO [Part 4 only]) | Up to 21 days | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of pulmonary function tests |
| Number of subjects with abnormal ophthalmological findings assessed by fundoscopy or OCT | Up to 21 days | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of ophthalmological assessments |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 21 days |
| Area under the plasma concentration-time curve (AUC) | Up to 21 days |
| Time of maximum observed plasma concentration (Tmax) | Up to 21 days |
| Apparent plasma terminal elimination half-life (T1/2) | Up to 21 days |
| The lowest absolute value of lymphocytes at postdose (nadir) | Up to 21 days |
| The lowest percentage of baseline (nadir [%]) | Up to 21 days |
| Time of nadir (Tnadir) | Up to 21 days |
| Area under the effectiveness curve (AUCE) | Up to 21 days |
Countries
United Kingdom
Outcome results
None listed